Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

Lilly

Status and phase: Completed; Phase 3

Conditions: Back Pain; Spinal Fracture; Osteoporosis, Postmenopausal

Treatments: Drug: teriparatide; Drug: placebo; Drug: risedronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00343252

B3D-MC-GHCY (Other Identifier)

9041

Details and patient eligibility

About

The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.

Enrollment: 712 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women 45 years or older. No period for at least two years.
• History of back pain that started at least 2 months prior to the initial visit (likely due to spinal bone fracture determined by investigator).
• Minimum of one moderate spinal bone fracture.
• Beginning pain level of at least four on an eleven point scale.
• Bone Mineral Density (BMD) must meet criteria
• Able to read, understand, and administer self-questionnaires.
• Be willing and able to use a pen-injector to deliver the medication.

Exclusion criteria

• Are at increased risk for osteosarcoma.
• Have an active or suspected diseases that affects bone metabolism other than osteoporosis.
• Participants that already know that they will require procedures to repair their spinal bone fractures.
• Abnormal values of certain lab tests.
• Anything that would make it difficult to determine if the back pain was due to the fracture.
• Poor medical or psychiatric condition.
• Alcohol or drug abuse within a year of the study start.
• Certain malignant neoplasms in the 5 years prior to enrollment.
• Active liver disease or clinical jaundice.
• Significantly impaired renal function.
• History of nephrolithiasis or urolithiasis within 2 years prior to enrollment.
• Known contraindication or intolerance to risedronate and/or teriparatide therapy.
• Treatment with oral strontium or certain therapeutic doses of fluoride.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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712 participants in 2 patient groups

Teriparatide

Experimental group

Description:

Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo

Treatment:

Drug: placebo

Drug: teriparatide

Drug: placebo

Risedronate

Active Comparator group

Description:

Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Treatment:

Drug: placebo

Drug: risedronate

Drug: placebo